Hypoallergenicity of a Hydrolyzed Rice Protein-based Formula in Infants and Young Children With C… (NCT06633289) | Clinical Trial Compass
CompletedNot Applicable
Hypoallergenicity of a Hydrolyzed Rice Protein-based Formula in Infants and Young Children With Cow's Milk Protein Allergy
Germany, Italy43 participantsStarted 2024-11-05
Plain-language summary
The purpose of the study is to determine whether a new hydrolyzed rice protein-based formula is hypoallergenic in infants and young children with documented Immunoglobulin E (IgE)-mediated Cow Milk Protein Allergy (CMPA).
Who can participate
Age range60 Days – 3 Years
SexALL
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Inclusion criteria
✓. Written informed consent has been obtained from at least one parent (or legally acceptable representative \[LAR\]), if applicable)
✓. Child gestational age ≥ 37 completed weeks
✓. Child aged ≥ 60 days and less than 36 months at enrollment
✓. Documented IgE-mediated CMPA no more than 6 months prior to enrollment
✓. Child is receiving a strict cow's milk elimination diet and will continue receiving this diet until the completion of the study
✓. Child's parent(s) and LAR (if applicable) is of legal age of majority, must have parental authority, must understand the informed consent form and other study documents, and are willing and able to fulfill the requirements of the study protocol
Exclusion criteria
✕. Child is exclusively breastfed
✕. Any chronic medical diseases (except atopic eczema), chromosomal or major congenital anomalies
✕. Congenital heart disease or treatment by B-blockers
✕. Major gastrointestinal disease / abnormalities (other than CMPA)
✕. Known or suspected soy allergy
✕. Glucose-galactose malabsorption
✕
What they're measuring
1
Hypoallergenicity of a Hydrolyzed Rice Protein-based Formula (Experimental Formula)
✕. Children who are unable to discontinue antihistamine use (excluding eye drops) within 7 days prior to a food challenge and oral steroid use within 14 days prior to enrollment